J A_Final_Redacted.pdf

Control Number: JA15281

“For Official Use Only”

JUSTIFICATION AND APPROVAL FOR OTHER THAN

FULL AND OPEN COMPETITION

1. Contracting Agency: The contracting activity for this action is the US Army Medical Research Acquisition Activity (USAMRAA) in support of the US Army Medical Research Institute of Chemical Defense (MRICD).

2. Description of Action: This approval is being requested for a firm-fixed price commercial supply buy for vials of human insulin-like growth factor-1(IGF-1 ) recombinant proteins, product # CYT-216 manufactureed from ProspecBio. . The supply item will be procured using Fiscal Year 2014 Research and Development fund.

3. Description of Supply: MRICD has a requirement to procure vials of Human IGF-1 recombinant proteins, product # CYT-216 manufactured by ProspecBio, Inc. IGF-1 is a growth factor which promotes and supports growth and development. It supports growth and maintenance of nerves and muscles. We have produced evidence suggesting that IGF-1 hhlps maintain muscles paralyzed by botulinum neurotoxin, reducing atrophy and accelerating recovery from paralysis. The total estimated value of this action, including shipping, is $100,000.

4. Authority Cited: In accordance with 10 U.S.C. 2304(c)(2) as implemented in Federal Acquisition Regulation (FAR) 6.302-2(a), the agency’s need for the supply is of such an unusual and compelling urgency that the Government would be seriously injured unless the agency is permitted to limit the number of sources from which it solicits bids, full and open competition need not be provided for.

5. Reason for Authority Cited: In accordance with FAR 6.302‐2(b), an unusual and compelling urgency precludes full and open competition and the delay in award of the contract would result in serious injury to the Government. If the Government cannot limit the sources, USAMRICD cannot accomplish its mission, discover and develop medical products and knowledge solutions against chemical and biochemical threats through research, education, and training, and consultation. The IGF‐1 from Prospec Bio is purified to greater than 98% by proprietary chromatographic methods; purity is determined by RP‐HPLC and SDS‐PAGE. Competing products are of less purity. Samples of IGF we have tried from other sources have not performed as well as the Prospec Bio product. In addition, IGF‐1 from other sources in as much as 20 times as expensive. The

IGF‐1 is being used for a research project at USAMRICD. IGF is injected twice daily in an animal model in research designed to develop countermeasures against intoxication by botulinum neurotoxin, which is a recognized threat agent for military and civilian personnel. The project supports research for the Defense Threat Reduction Agency

(DTRA) which has milestones that must be met over the next several months. The project involves use of IGF‐1 and there is no alternative compound for performing the work other than IGF‐1. There are no other aspects of this project that can be performed without this compound. The stock of IGF on hand will be completely expended by 5 July

2015, and the research will necessarily halt until additional quantities of IGF can be obtained. The result will be that milestones will not be met and mission failure will result.

6. Efforts to Obtain Competition: A similar list of items was found marketed by Sigma- Aldrich under the names IGF-1. These include Human IGF-1 (#I2656). However, these products fail to meet the minimum essential characteristics (MECs) defined for our assay.

No other vendors were found with a similar product that meets the guidelines of the MECs.

7. Actions to Increase Competition: It is the policy of USAMRAA to promote the use of competitive procedures whenever and wherever possible. However, this is a unique item that makes efforts to increase competition very difficult. Market research with future procurements of this nature will include a search for competitive manufacturers. A Sources Sought Notice will be posted in the future to locate other possible vendors that can provide either the required brand or another brand that can meet the Government’s requirements.

8. Market Research: Market research was conducted in May-June 2015 by internet searches and extended communication with sales representatives in the recombinant protein field.

Web searches and queries of other subject matter experts in the research field were conducted to verify that this product is sole source. The resulting determination was that although there are other vendors with similar products, they fail to meet the guidelines indicated in the minimum essential characteristics (MECs). A similar list of items was found marketed by Sigma-Aldrich under the names IGF-1. These include Human IGF-1 (#I2656). However, these products fail to meet the minimum essential characteristics (MECs) defined for our assay. Their purity is less and their assays are less stringent, and the samples we have evaluated do not perform as well as the Prospec Bio product. The MECs used in our protocol were also used as a guideline. There are several resellers within the United States that service the local area that can provide ProspecBio’s IGF-1 Human recombinant proteins. This requirement will be solicted among the following authorized resellers: E-Enzyme, 401 Professional Drive, Suite 160, Gaithersburg, MD 20879; Speed BioSystems, 900 Clopper Road, Suite 130, Gaithersburg, MD 20878; and Denovo BioTech, 9639 Dr. Perry Road, Suite 109, Ijamsville, MD 21754.

9. Interested Sources: This is a specialized requirement for IGF-1 Human recombinant proteins and there are no other interested sources known to date that meet the MECs. Due to the urgent nature of requirement, the Government is exempt from posting an Synopsis of award action per FAR Part 5.202(2)(2) when using the FAR Authority 6.302-2,

10. Other Facts: Extensive market research was conducted in an effort to identify alternative sources of suitable IGF-1 recombinant proteins (rat, mouse and human). No other sources have found to meet the agency’s requirement.

a. Procurement history.

(1) Contract numbers and dates of the last several contracts for these same requirements. No other requirements for this exact item.

(2) Competitive status of these actions. N/A

(3) Authority previously used for less than full and open competition. N/A

(4) If a justification was prepared to support the procurement made before this one, a summary of the contents of paragraph 7 of the justification for that procurement and an explanation of the results. N/A

(5) If any prior award was accomplished by full and open competition, a detailed explanation of the changed circumstances. N/A

(6) An explanation of any unusual patterns which may be revealed by the history, e.g. several consecutive urgent buys. N/A

(7) If a justification was prepared to support the procurement made before this one, briefly describe the circumstances justifying the buy and whether there have been any significant changes. N/A

b. Other facts. Provide any other facts necessary to justify limiting competition that were not previously stated. N /A

Title: __Contracting Officer_____ Signatu